Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation

ImmunityBio, Inc.1 site in 1 country45 target enrollmentAugust 3, 2020

ConditionsCOVID

InterventionsBM-Allo.MSC Placebo

DrugsBM-Allo.MSC Placebo

Overview

Phase: Phase 1
Intervention: BM-Allo.MSC
Conditions: COVID
Sponsor: ImmunityBio, Inc.
Enrollment: 45
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events Within 30 Days of Randomization
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19 infection.

Registry

clinicaltrials.gov

Start Date

August 3, 2020

End Date

June 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ImmunityBio, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old.
•Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. For subjects that are intubated and/or sedated, or otherwise unable to provide consent, prospective consent from a legally-authorized representative is required. The subject or his/her legally authorized representative must be able to provide consent.
•Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen \< 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp).
•Requiring mechanical ventilatory support with moderate to severe Acute Respiratory Distress Syndrome (ARDS) as determined by the Berlin criteria:
•Bilateral opacities present on a chest radiograph or computed tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
•Origin of Edema: Respiratory failure not fully explained by cardiac failure or fluid overload.
•Oxygenation: Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
•Moderate: PaO2/FiO2 \>100 mmHg and ≤ 200 mmHg, on ventilator settings that include PEEP ≥ 5 cm H2O
•Severe: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O Subjects receiving extracorporeal membrane oxygenation (ECMO) will not be enrolled in this study.
•High-sensitivity C-reactive Protein (hs-CRP) serum level \> 4.0 mg/dL

Exclusion Criteria

•Known hypersensitivity to any component of the study medication(s).
•Signs of multisystem organ failure. Liver function tests (LFTs) \> 5x normal.
•Intubated \> 72 continuous hours.
•Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
•Pregnant and nursing women. A negative serum pregnancy test during screening (within 72 hours prior to the first dose) must be documented before MSCs are administered to a female subject of child-bearing potential.